FDA Registration
Active
🇺🇸 United States
BREG, INC.
Reg #: 3010694026
·
FEI: 3010694026
·
Expires 2026
Products
33
Proprietary Names
274
Establishment Types
1
Classifications
33
Registration Details
- Registration Name
- BREG, INC.
- Registration Number
- 3010694026
- FEI Number
- 3010694026
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2835 Fortune Cir W
- City
- Indianapolis
- State
- IN
- ZIP
- 46241
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202839
Owner / Operator
- Firm Name
- Breg Inc
- Operator Number
- 10041297
- Address
- 2382 Faraday Avenue, Suite 300
- City
- Carlsbad
- State
- CA
- Postal Code
- 92008
- Country
- US
- Correspondent
- Monique Zamora
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2013-07-16 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2012-07-27 |
| Cane | IPS | Class 1 | Physical Medicine | No | 2020-03-11 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2024-11-08 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 2020-03-11 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2012-08-31 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2013-01-30 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2012-08-17 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2012-08-17 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2012-08-17 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2013-03-25 |
| Shoe, Cast | IPG | Class 1 | Physical Medicine | No | 2012-08-17 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2012-07-10 |
| Tape, Orthopedic | HXT | Class 1 | General, Plastic Surgery | No | 2022-06-07 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 2022-06-07 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2017-02-01 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2012-08-17 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2012-08-17 |
| Insoles, Medical | KYS | Class 1 | General Hospital | No | 2012-08-17 |
| Massager, Powered Inflatable Tube | IRP | Class 2 | Physical Medicine | No | 2019-06-12 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2014-05-12 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2015-05-17 |
| Orthosis, Abdominal | KTD | Class 1 | Physical Medicine | No | 2017-02-01 |
| Splint, Temporary Training | IQM | Class 1 | Physical Medicine | No | 2012-08-17 |
| Cushion, Flotation | KIC | Class 1 | Physical Medicine | No | 2022-06-07 |
| Sling, Arm, Overhead Supported | ILE | Class 1 | Physical Medicine | No | 2022-06-07 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2012-08-17 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2012-07-27 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2020-03-11 |
| Components, Exercise | IOD | Class 1 | Physical Medicine | No | 2012-08-17 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2012-08-17 |
| Orthosis, Rib Fracture, Soft | IPX | Class 1 | Physical Medicine | No | 2017-02-01 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 2012-08-17 |
Proprietary Names
Pro-Fitt TLSO
Actimove Loc 462
Ascend TLSO 456/457
Pinnacle TLSO 464
Epic LP TLSO 456
Accessories - Conversion Pad, Extension Panel
IntelliFlo Pads
Wrap on Polar Pads
Glacier, Glacier Combo
Kodiak, Kodiak Combo
Cube, Cube Combo
Accessories - Y-Adapter, Transformer, Strap, Battery Pack, Bed Hanger, Extension Tube
Canes
DVT Guardian
Crutches
Polar Care Cub, Cub Combo
Breg Ice Bags
Polar Pad
Cervical Collar
Cervical Traction Kit
Pinnacle 172/174/180
Ascend Pediatric Collar
Ascend Cervical Collar
Pinnacle CTO4
Pinnacle CTO
Accessories - Back Panel, Front Panel, Pad Kit, Upgrade Kit, Conversion Kit, Pads
Carlsbad Cervical Collar
Gel Pad
Gel Wrap
Cryo Pad Universal
Polar Wraps
Gel Pack
Abdominal Binder
Cervical Collar Serpentine
Clavicle Support
Cervical Collar with Open Trachea
Intelli-Flo Dressing
Polar Dressing
T-Scope Hip
Simple Pelvic
Centron Hip
Philippon
Accessories - Surgical Kit, Surgical Boot, Peroneal Post, Thigh/Pelvic Pad, Cuff, Strap clip, Y-Tab
POST-OP SHOE PED
POST-OP SHOE MENS & WOMENS
SQ TOE POST-OP SHOE
KNOCKOUT WRIST
NEUTRAL HAND ATTACHMENT
CX2K
ESSENTIAL ELBOW IMMOB
THIGH SUPPORT
STACK FINGER SPLINT
TENNIS ELBOW STRAP
ADJ DONUT
CALF SLEEVE
ADJ NIGHT SPLINT
PHX
HAND EXT
TENDON COMPRESSION STRAP
UNIVERSAL HORESHOE
HINGED KNEE BRACE
SOFTGAIT
ALIGNER PHX
WRIST LACER
KNEE SUPPORT
ELBOW TSCOPE
BUTTRESS SUPPORT
LAT STABILIZER
X2K ELBOW
M-BRACE
PATELLA STABILIZER
T-CHECK
LACE UP ANKLE
ARC DYNAMIC
Synthocast
Maternity Belt
ABDUCTION PILLOW CONTOURED
FastForm SCB VERSI Strip
FastForm SCB Universal Gutter Multifunctional Orthosis
FastForm Wrist Cast
FastForm SCB Hook & Loop refresh Strips
FastForm SCB Short Arm Multifunctional Orthosis
FastForm SCB Thumb Spica Multifunctional Orthosis
Elasto-Fit Wrist Support
Vinyl Splint
Thumb Support
Wrist Guard
Universal Wrist Splint
Universal Wrist Brace
Classic Wrist Brace
Versafit Wrist Brace
Versafit Thumb
Contender Brace
Wrist Stabilizer Cock-Up
Thumb Guard
Wrist Cock Up Splint
Thumbster
Low Profile Wrist
Premier Thumb Splint
Wrist Mate
Wrist Lacer
Wrist Pro
Apollo Wrist Brace
Wrist Complete
FastForm SCB Immobilizer
FastForm SCB Hand-based thumb Spica Orthosis
FastForm SCB Tension Straps
Universal Thumb Lacer
FastForm SCB VERSI Sheet
Deluxe Shoulder Sling
Arc 2
Essential Shoulder Immob.
Essential Shoulder Sling
Shoulder Immob. Deluxe
Slingshot 3
Shoulder Abduction Pillow
Slingshot
Neutral Wedge
Atlas Shoulder Brace
Curtis Shoulder Sleeve
Kool Sling
Sling and Swathe Universal
Curtis Shoulder Cuff
Slingshot 2
Straight Shoulder Immobilizer
Accessories - Waistband Strap, Shoulder Stabilizer, Sling Pediatric
Accessories - Extension Strap, Closure Extension, Shoulder Strap, Hand Attachment, Shoulder Pad, Abduction Pillow
PRESSURE RELIEF PAD
Silicone Heel Cup
Heel Lift
Polar Care Wave
Cold Compression Pad
Transformer
Y-Adapter
VOLLEY TENNIS ELBOW
Universal Arm Elevator
Ortholux
Ace
Centron
Lumbolux
Ninja
Vertalux
Extender
Surgical Binder
Plantar Fascitic Soft Night Splint
Bunion Splint
Night Splint
Viscoelastic Insole
Ambulite Elbow
VPulse
Podus Guard
Dorsal Night Splint
Heelbo
Wee Walker
Achilles Boot
Ultimate Ankle
Axiom Ankle
Integrity Walker
Mid-Calf Boot
AdjustaFit Boot
Flatform Boot
J Walker
Conformer
ProGait
Bunion Boot
Boot Cover
Charcot Conformer
Plantar Fasciitis Splint
Hi Top / Lo Top
Performance Knit Ankle
Ankle Quick Wrap
Wraptor
VersaStrap Ankle
Ankle Lace up
Ankle Elastic Support
Multi-Stay Ankle
Shell Ankle Walker
KoolAir Ankle
Controlled ROM Walker
Ankle Sprain Kit
Boot Acsy Kit Extension Strap
Ankle Stirrup
Silicone Elastic Ankle Support
Mini Walker
Vectra Walker
Ankle Brace Lock (ABL)
Pin Cam Walker
Ultra Ankle
Ankle Walker
Vectra Pro Walker
Vectra Wee Walker
Achilles Wedge
Accessories - Cuff Kit, Bootie, Pads, Air Bladder, Straps
Tri-Panel Knee Immob
Original Knee
OR Merit
Z-13
Axiom
Wee-Rom
Z-12
20.50 Patellofemoral
DUO
Jet
Thruster RLF
Revolution 3
G3
Extender Plus
Quantum OA
T-Scope Premier
Post-Op
LPR
Latitude OA Knee
Genesis
Undersleeve
Patella Guard
Hi-Performance
Hinged Knee
FreeRunner
Lateral Stabilizer
EPO
Recover
X2K Knee Brace
OA Impulse
Economy Hinged Knee
Slide Guard
ShortRunner
PTO
Crossover
Hinge Cover
RoadRunner
Freestyle
FreeSport
Solus Knee Brace
Fusion Knee
Accessories - Condyle and Hook, Patella Buttress, Strap set, Strap Tab, Strap Pad, Calf Strap, Condyle, Hex Key
MC Knee Brace
Knee Support
Accessories - Stop Kit, Soft Toe Guard, Soft Goods, Shoe Insert, Buckle, Chafe Tab, Shoe insert, Hard toe guard
Accessories - Incision Pad, Pad, Pad Kit, Refurb Kit, Cuff, Wrap Set, Hinge Kit, Shims Kit
CrossRunner
Performance Knit Hinged
Measuring System, Fit Kit
Freestyle Plus
TopShelf Fusion Strap Set
Single Panel Knee Immob
Walkers
Ankle Therapy Kit
Knee Therapy Kit
Shoulder Therapy Kit
System Loc
Actimove Fit 627
Actimove Fit 631
Actimove Fit 637
V-Loc
Cinch Loc
Lumbar Loc
Pro-Fitt LSO
Core Loc
Deluxe
Pinnacle 627/631/637/639
Ascend SI
Ascend 627/631/637
Epic LP LO627/LSO631/LSO637
Lumbar Support
Back Support
BOA Back Brace
Accessories - Extension Panel, Pad Kit, Upgrade Kit, Back Pad
Essential Spine 627/642, 631/648, 637/650
Pinnacle Belt/LSO
Ascend LSO
Rib Belt
Elbow/Knee Sleeve
Brace Cover
Suspension Sleeve
Establishment Types
Repack or Relabel Medical Device